News

FDA Publishes Full Texts of Response Letters to Drug Applications
By Stephanie Brown HealthDay ReporterTHURSDAY, July 10, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has ...
BioSpace6d
FDA Publishes Cache of Complete Response Letters in Bid for ‘Radical Transparency’
The trove of more than 200 letters is part of a pledge of transparency from the agency, with the intention to increase public ...
MedPage Today2h
CRLs Are the Low-Hanging Fruit of FDA Transparency, Experts Say
For instance, "the backlog of FOIAs ... is enormous," he said. Califf said the FDA has far greater opportunities for improved ...
BioSpace6d
FDA Rejections: We Read 200 CRLs So You Don’t Have To
A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...
US FDA publishes 200 complete response letters from archive in transparency drive
The U.S. Food and Drug Administration released more than 200 of its so-called complete response letters from its archive on ...
Cancer Therapy Advisor6d
FDA Publishes Complete Response Letters for Drug Applications
The FDA has published more than 200 complete response letters, sent as replies for applications submitted from 2020 to 2024.
The Manila Times5d
Ultragenyx Receives Complete Response Letter from FDA for UX111 AAV Gene Therapy to Treat Sanfilippo Syndrome Type A (MPS IIIA)
Complete Response Letter (CRL) cited specific chemistry, manufacturing and controls (CMC) related observations that are ...
Ophthalmology Times4h
FDA accepts for review Aldeyra Therapeutics’ resubmitted New Drug Application for reproxalap
The FDA accepted Aldeyra's resubmitted NDA for reproxalap after previous rejections due to efficacy concerns, despite no ...
JD Supra3d
FDA Publishes More Than 200 Complete Response Letters (CRLs) With More to Come
On July 10, 2025, the Food and Drug Administration (FDA) announced that it had published more than 200 complete response letters (CRLs), in ...
PharmTech5d
FDA Publishes More Than 200 Complete Response Letters
FDA says the move boosts regulatory transparency, offering insights into common approval barriers in drug applications and reducing guesswork.
FDA publishes more than 200 rejection letters in a bid to improve transparency
The U.S. FDA publishes over 200 complete response letters to enhance transparency within the agency. Read more here.
FDA rejects Ultragenyx gene therapy over manufacturing concerns
While the CRL derails a near-term clearance, one analyst described the rejection as more of “a speed bump to approval, rather ...